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Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314637
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : January 2, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Teneligliptin
Drug: Teneligliptin + Sulfonylurea
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea
Hide Arm/Group Description Teneligliptin for 52 weeks Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
Period Title: Overall Study
Started 151 89
Completed 135 75
Not Completed 16 14
Reason Not Completed
Adverse Event             4             8
Lack of Efficacy             1             0
Physician Decision             5             2
Withdrawal by Subject             5             4
Other Reason             1             0
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea Total
Hide Arm/Group Description Teneligliptin for 52 weeks Teneligliptin for 52 weeks in combination with sulfonylurea Total of all reporting groups
Overall Number of Baseline Participants 151 89 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 89 participants 240 participants
<65 years 108 65 173
>=65 years 43 24 67
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 89 participants 240 participants
Female
56
  37.1%
33
  37.1%
89
  37.1%
Male
95
  62.9%
56
  62.9%
151
  62.9%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea
Hide Arm/Group Description:
Teneligliptin for 52 weeks
Teneligliptin for 52 weeks in combination with sulfonylurea
Overall Number of Participants Analyzed 151 89
Measure Type: Number
Unit of Measure: participants
Serious Adverse Event 6 7
Other Adverse Event 136 84
2.Secondary Outcome
Title Change From Baseline in HbA1c at Week 52
Hide Description [Not Specified]
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea
Hide Arm/Group Description:
Teneligliptin for 52 weeks
Teneligliptin for 52 weeks in combination with sulfonylurea
Overall Number of Participants Analyzed 151 89
Mean (Standard Deviation)
Unit of Measure: percent
-0.63  (0.67) -0.81  (0.76)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 52
Hide Description [Not Specified]
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea
Hide Arm/Group Description:
Teneligliptin for 52 weeks
Teneligliptin for 52 weeks in combination with sulfonylurea
Overall Number of Participants Analyzed 151 88
Mean (Standard Deviation)
Unit of Measure: mg/dL
-12.4  (22.9) -17.0  (30.5)
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Teneligliptin Teneligliptin + Sulfonylurea
Hide Arm/Group Description Teneligliptin for 52 weeks Teneligliptin for 52 weeks in combination with sulfonylurea
All-Cause Mortality
Teneligliptin Teneligliptin + Sulfonylurea
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Teneligliptin Teneligliptin + Sulfonylurea
Affected / at Risk (%) Affected / at Risk (%)
Total   6/151 (3.97%)   7/89 (7.87%) 
Ear and labyrinth disorders     
Sudden hearing loss  1/151 (0.66%)  0/89 (0.00%) 
Gastrointestinal disorders     
Gastritis  1/151 (0.66%)  0/89 (0.00%) 
Intestinal obstruction  1/151 (0.66%)  0/89 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  0/151 (0.00%)  1/89 (1.12%) 
Cholelithiasis  0/151 (0.00%)  1/89 (1.12%) 
Infections and infestations     
Diverticulitis  1/151 (0.66%)  0/89 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  0/151 (0.00%)  1/89 (1.12%) 
Joint sprain  0/151 (0.00%)  1/89 (1.12%) 
Spinal compression fracture  0/151 (0.00%)  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1/151 (0.66%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  0/151 (0.00%)  1/89 (1.12%) 
Large intestine carcinoma  1/151 (0.66%)  0/89 (0.00%) 
Testicular neoplasm  0/151 (0.00%)  1/89 (1.12%) 
Nervous system disorders     
Myelopathy  0/151 (0.00%)  1/89 (1.12%) 
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Teneligliptin Teneligliptin + Sulfonylurea
Affected / at Risk (%) Affected / at Risk (%)
Total   136/151 (90.07%)   84/89 (94.38%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1/151 (0.66%)  0/89 (0.00%) 
Cardiac disorders     
Angina pectoris  0/151 (0.00%)  1/89 (1.12%) 
Ear and labyrinth disorders     
Meniere’s disease  3/151 (1.99%)  0/89 (0.00%) 
Tinnitus  2/151 (1.32%)  2/89 (2.25%) 
Vertigo  4/151 (2.65%)  1/89 (1.12%) 
Vertigo positional  1/151 (0.66%)  0/89 (0.00%) 
Ear discomfort  1/151 (0.66%)  0/89 (0.00%) 
Sudden hearing loss  1/151 (0.66%)  0/89 (0.00%) 
Endocrine disorders     
Thyroid mass  1/151 (0.66%)  0/89 (0.00%) 
Eye disorders     
Abnormal sensation in eye  0/151 (0.00%)  1/89 (1.12%) 
Cataract  4/151 (2.65%)  0/89 (0.00%) 
Conjunctival granuloma  1/151 (0.66%)  0/89 (0.00%) 
Conjunctivitis  2/151 (1.32%)  0/89 (0.00%) 
Conjunctivitis allergic  1/151 (0.66%)  1/89 (1.12%) 
Diabetic retinopathy  2/151 (1.32%)  1/89 (1.12%) 
Dry eye  0/151 (0.00%)  1/89 (1.12%) 
Keratitis  0/151 (0.00%)  1/89 (1.12%) 
Macular oedema  1/151 (0.66%)  0/89 (0.00%) 
Strabismus  1/151 (0.66%)  0/89 (0.00%) 
Vision blurred  1/151 (0.66%)  0/89 (0.00%) 
Vitreous detachment  1/151 (0.66%)  0/89 (0.00%) 
Vitreous floaters  0/151 (0.00%)  1/89 (1.12%) 
Entropion  1/151 (0.66%)  0/89 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  2/151 (1.32%)  1/89 (1.12%) 
Abdominal distension  0/151 (0.00%)  1/89 (1.12%) 
Abdominal pain upper  2/151 (1.32%)  1/89 (1.12%) 
Anal fissure  1/151 (0.66%)  0/89 (0.00%) 
Cheilitis  2/151 (1.32%)  1/89 (1.12%) 
Colonic polyp  5/151 (3.31%)  3/89 (3.37%) 
Constipation  5/151 (3.31%)  2/89 (2.25%) 
Dental caries  2/151 (1.32%)  2/89 (2.25%) 
Diarrhoea  6/151 (3.97%)  0/89 (0.00%) 
Duodenal ulcer  0/151 (0.00%)  1/89 (1.12%) 
Duodenitis  0/151 (0.00%)  1/89 (1.12%) 
Dyspepsia  1/151 (0.66%)  2/89 (2.25%) 
Enterocolitis  0/151 (0.00%)  1/89 (1.12%) 
Faeces hard  1/151 (0.66%)  0/89 (0.00%) 
Food poisoning  1/151 (0.66%)  0/89 (0.00%) 
Gastric polyps  5/151 (3.31%)  5/89 (5.62%) 
Gastritis  5/151 (3.31%)  6/89 (6.74%) 
Gastritis erosive  1/151 (0.66%)  1/89 (1.12%) 
Gingivitis  1/151 (0.66%)  1/89 (1.12%) 
Haemorrhoids  3/151 (1.99%)  2/89 (2.25%) 
Hiatus hernia  0/151 (0.00%)  1/89 (1.12%) 
Inguinal hernia  1/151 (0.66%)  1/89 (1.12%) 
Nausea  2/151 (1.32%)  0/89 (0.00%) 
Periodontal disease  2/151 (1.32%)  1/89 (1.12%) 
Periodontitis  1/151 (0.66%)  1/89 (1.12%) 
Rectal polyp  0/151 (0.00%)  1/89 (1.12%) 
Reflux oesophagitis  3/151 (1.99%)  1/89 (1.12%) 
Stomatitis  3/151 (1.99%)  1/89 (1.12%) 
Toothache  1/151 (0.66%)  1/89 (1.12%) 
Vomiting  1/151 (0.66%)  1/89 (1.12%) 
Gastroduodenitis  1/151 (0.66%)  0/89 (0.00%) 
General disorders     
Chest discomfort  1/151 (0.66%)  1/89 (1.12%) 
Chest pain  1/151 (0.66%)  0/89 (0.00%) 
Malaise  1/151 (0.66%)  1/89 (1.12%) 
Oedema peripheral  0/151 (0.00%)  1/89 (1.12%) 
Pain  1/151 (0.66%)  0/89 (0.00%) 
Pyrexia  0/151 (0.00%)  1/89 (1.12%) 
Vaccination site dermatitis  1/151 (0.66%)  0/89 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1/151 (0.66%)  0/89 (0.00%) 
Hepatic steatosis  2/151 (1.32%)  1/89 (1.12%) 
Hyperplastic cholecystopathy  1/151 (0.66%)  0/89 (0.00%) 
Gallbladder polyp  2/151 (1.32%)  0/89 (0.00%) 
Immune system disorders     
Seasonal allergy  0/151 (0.00%)  2/89 (2.25%) 
Infections and infestations     
Acute tonsillitis  0/151 (0.00%)  1/89 (1.12%) 
Bronchitis  9/151 (5.96%)  8/89 (8.99%) 
Cellulitis  1/151 (0.66%)  1/89 (1.12%) 
Chronic sinusitis  1/151 (0.66%)  0/89 (0.00%) 
Cystitis  3/151 (1.99%)  2/89 (2.25%) 
Dermatitis infected  0/151 (0.00%)  1/89 (1.12%) 
Folliculitis  0/151 (0.00%)  1/89 (1.12%) 
Gastroenteritis  3/151 (1.99%)  1/89 (1.12%) 
Herpes zoster  2/151 (1.32%)  1/89 (1.12%) 
Hordeolum  0/151 (0.00%)  2/89 (2.25%) 
Influenza  1/151 (0.66%)  1/89 (1.12%) 
Laryngitis  1/151 (0.66%)  0/89 (0.00%) 
Nasopharyngitis  56/151 (37.09%)  29/89 (32.58%) 
Onychomycosis  5/151 (3.31%)  1/89 (1.12%) 
Otitis media  1/151 (0.66%)  0/89 (0.00%) 
Otitis media chronic  1/151 (0.66%)  0/89 (0.00%) 
Pharyngitis  8/151 (5.30%)  4/89 (4.49%) 
Pulpitis dental  0/151 (0.00%)  1/89 (1.12%) 
Rhinitis  0/151 (0.00%)  1/89 (1.12%) 
Tinea pedis  7/151 (4.64%)  2/89 (2.25%) 
Tonsillitis  1/151 (0.66%)  0/89 (0.00%) 
Vulvitis  1/151 (0.66%)  0/89 (0.00%) 
Vulvovaginitis  1/151 (0.66%)  0/89 (0.00%) 
Wound infection  1/151 (0.66%)  0/89 (0.00%) 
Gastritis viral  0/151 (0.00%)  1/89 (1.12%) 
Helicobacter infection  0/151 (0.00%)  1/89 (1.12%) 
Myringitis  0/151 (0.00%)  1/89 (1.12%) 
Enterocolitis viral  1/151 (0.66%)  0/89 (0.00%) 
Cystitis bacterial  0/151 (0.00%)  1/89 (1.12%) 
Oral herpes  2/151 (1.32%)  1/89 (1.12%) 
Latent syphilis  1/151 (0.66%)  0/89 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod sting  3/151 (1.99%)  1/89 (1.12%) 
Chillblains  1/151 (0.66%)  0/89 (0.00%) 
Foot fracture  1/151 (0.66%)  0/89 (0.00%) 
Humerus fracture  0/151 (0.00%)  1/89 (1.12%) 
Joint sprain  3/151 (1.99%)  1/89 (1.12%) 
Muscle injury  1/151 (0.66%)  0/89 (0.00%) 
Radius fracture  1/151 (0.66%)  1/89 (1.12%) 
Ulna fracture  0/151 (0.00%)  1/89 (1.12%) 
Wrist fracture  0/151 (0.00%)  1/89 (1.12%) 
Excoriation  2/151 (1.32%)  1/89 (1.12%) 
Contusion  9/151 (5.96%)  5/89 (5.62%) 
Thermal burn  1/151 (0.66%)  0/89 (0.00%) 
Skin laceration  0/151 (0.00%)  1/89 (1.12%) 
Open wound  1/151 (0.66%)  2/89 (2.25%) 
Heat illness  1/151 (0.66%)  1/89 (1.12%) 
Investigations     
Alanine aminotransferase increased  3/151 (1.99%)  3/89 (3.37%) 
Albumin urine present  2/151 (1.32%)  0/89 (0.00%) 
Aspartate aminotransferase increased  2/151 (1.32%)  3/89 (3.37%) 
Blood creatine phosphokinase increased  14/151 (9.27%)  7/89 (7.87%) 
Blood creatinine increased  0/151 (0.00%)  1/89 (1.12%) 
Blood potassium increased  5/151 (3.31%)  3/89 (3.37%) 
Blood triglycerides increased  3/151 (1.99%)  2/89 (2.25%) 
Blood uric acid increased  4/151 (2.65%)  2/89 (2.25%) 
Eosinophil count increased  1/151 (0.66%)  1/89 (1.12%) 
Gamma-glutamyltransferase increased  5/151 (3.31%)  3/89 (3.37%) 
Glucose urine present  9/151 (5.96%)  16/89 (17.98%) 
Blood urine present  11/151 (7.28%)  5/89 (5.62%) 
Monocyte count decreased  1/151 (0.66%)  0/89 (0.00%) 
White blood cell count increased  1/151 (0.66%)  1/89 (1.12%) 
Protein urine present  14/151 (9.27%)  13/89 (14.61%) 
Urine ketone body present  2/151 (1.32%)  5/89 (5.62%) 
Blood alkaline phosphatase increased  1/151 (0.66%)  1/89 (1.12%) 
Occult blood positive  1/151 (0.66%)  0/89 (0.00%) 
Metabolism and nutrition disorders     
Gout  0/151 (0.00%)  1/89 (1.12%) 
Hyperuricaemia  0/151 (0.00%)  1/89 (1.12%) 
Hypoglycaemia  5/151 (3.31%)  9/89 (10.11%) 
Decreased appetite  1/151 (0.66%)  0/89 (0.00%) 
Hyperlipidaemia  1/151 (0.66%)  2/89 (2.25%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  11/151 (7.28%)  3/89 (3.37%) 
Arthritis  1/151 (0.66%)  0/89 (0.00%) 
Back pain  7/151 (4.64%)  2/89 (2.25%) 
Fasciitis  0/151 (0.00%)  1/89 (1.12%) 
Joint effusion  1/151 (0.66%)  0/89 (0.00%) 
Lumbar spinal stenosis  1/151 (0.66%)  0/89 (0.00%) 
Monarthritis  1/151 (0.66%)  0/89 (0.00%) 
Muscle spasms  1/151 (0.66%)  1/89 (1.12%) 
Musculoskeletal pain  1/151 (0.66%)  0/89 (0.00%) 
Myalgia  2/151 (1.32%)  0/89 (0.00%) 
Osteoarthritis  1/151 (0.66%)  6/89 (6.74%) 
Osteoporosis  1/151 (0.66%)  0/89 (0.00%) 
Pain in extremity  0/151 (0.00%)  1/89 (1.12%) 
Periarthritis  3/151 (1.99%)  1/89 (1.12%) 
Plantar fasciitis  1/151 (0.66%)  0/89 (0.00%) 
Spinal osteoarthritis  3/151 (1.99%)  2/89 (2.25%) 
Tenosynovitis  3/151 (1.99%)  0/89 (0.00%) 
Trigger finger  1/151 (0.66%)  2/89 (2.25%) 
Musculoskeletal stiffness  1/151 (0.66%)  3/89 (3.37%) 
Tenosynovitis stenosans  0/151 (0.00%)  1/89 (1.12%) 
Spinal ligament ossification  0/151 (0.00%)  1/89 (1.12%) 
Spondylolisthesis  0/151 (0.00%)  1/89 (1.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acrochordon  0/151 (0.00%)  1/89 (1.12%) 
Skin papilloma  0/151 (0.00%)  1/89 (1.12%) 
Uterine leiomyoma  1/151 (0.66%)  0/89 (0.00%) 
Gastrointestinal neoplasm  2/151 (1.32%)  0/89 (0.00%) 
Nervous system disorders     
Cervicobrachial syndrome  1/151 (0.66%)  1/89 (1.12%) 
Diabetic neuropathy  4/151 (2.65%)  0/89 (0.00%) 
Dizziness  1/151 (0.66%)  1/89 (1.12%) 
Dizziness postural  2/151 (1.32%)  0/89 (0.00%) 
Headache  7/151 (4.64%)  0/89 (0.00%) 
Migraine  1/151 (0.66%)  0/89 (0.00%) 
Somnolence  1/151 (0.66%)  0/89 (0.00%) 
Tension headache  0/151 (0.00%)  2/89 (2.25%) 
Carotid arteriosclerosis  3/151 (1.99%)  0/89 (0.00%) 
Occipital neuralgia  1/151 (0.66%)  0/89 (0.00%) 
Psychiatric disorders     
Anxiety  1/151 (0.66%)  0/89 (0.00%) 
Depression  1/151 (0.66%)  0/89 (0.00%) 
Insomnia  6/151 (3.97%)  9/89 (10.11%) 
Schizophrenia  0/151 (0.00%)  1/89 (1.12%) 
Somatoform disorder gastrointestinal  0/151 (0.00%)  1/89 (1.12%) 
Anxiety disorder  1/151 (0.66%)  0/89 (0.00%) 
Renal and urinary disorders     
Hypertonic bladder  0/151 (0.00%)  1/89 (1.12%) 
Nephrolithiasis  3/151 (1.99%)  0/89 (0.00%) 
Pollakiuria  0/151 (0.00%)  1/89 (1.12%) 
Urinary incontinence  1/151 (0.66%)  0/89 (0.00%) 
Diabetic nephropathy  0/151 (0.00%)  1/89 (1.12%) 
Pyelocaliectasis  0/151 (0.00%)  1/89 (1.12%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1/151 (0.66%)  1/89 (1.12%) 
Calculus prostatic  1/151 (0.66%)  0/89 (0.00%) 
Dysmenorrhoea  1/151 (0.66%)  0/89 (0.00%) 
Menstruation irregular  1/151 (0.66%)  0/89 (0.00%) 
Prostatitis  2/151 (1.32%)  0/89 (0.00%) 
Uterine prolapse  1/151 (0.66%)  0/89 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1/151 (0.66%)  0/89 (0.00%) 
Cough  1/151 (0.66%)  0/89 (0.00%) 
Rhinitis allergic  6/151 (3.97%)  0/89 (0.00%) 
Sneezing  1/151 (0.66%)  0/89 (0.00%) 
Upper respiratory tract inflammation  9/151 (5.96%)  10/89 (11.24%) 
Laryngeal granuloma  1/151 (0.66%)  0/89 (0.00%) 
Upper-airway cough syndrome  1/151 (0.66%)  0/89 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1/151 (0.66%)  1/89 (1.12%) 
Dermatitis  1/151 (0.66%)  0/89 (0.00%) 
Dermatitis allergic  1/151 (0.66%)  0/89 (0.00%) 
Dermatitis atopic  1/151 (0.66%)  1/89 (1.12%) 
Dermatitis contact  3/151 (1.99%)  0/89 (0.00%) 
Dry skin  1/151 (0.66%)  0/89 (0.00%) 
Eczema  8/151 (5.30%)  3/89 (3.37%) 
Eczema asteatotic  1/151 (0.66%)  1/89 (1.12%) 
Haemorrhage subcutaneous  1/151 (0.66%)  0/89 (0.00%) 
Heat rash  1/151 (0.66%)  1/89 (1.12%) 
Hyperkeratosis  1/151 (0.66%)  0/89 (0.00%) 
Papule  1/151 (0.66%)  0/89 (0.00%) 
Pruritus  3/151 (1.99%)  0/89 (0.00%) 
Pustular psoriasis  1/151 (0.66%)  0/89 (0.00%) 
Rash  4/151 (2.65%)  1/89 (1.12%) 
Rash generalised  1/151 (0.66%)  0/89 (0.00%) 
Seborrhoeic dermatitis  1/151 (0.66%)  0/89 (0.00%) 
Skin nodule  1/151 (0.66%)  0/89 (0.00%) 
Urticaria  0/151 (0.00%)  1/89 (1.12%) 
Xeroderma  1/151 (0.66%)  0/89 (0.00%) 
Pruritus generalised  0/151 (0.00%)  1/89 (1.12%) 
Vascular disorders     
Hypertension  8/151 (5.30%)  0/89 (0.00%) 
Orthostatic hypotension  1/151 (0.66%)  0/89 (0.00%) 
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
EMail: cti-inq-ml@ml.mt-pharma.co.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02314637     History of Changes
Other Study ID Numbers: 3000-A8
First Submitted: December 8, 2014
First Posted: December 11, 2014
Results First Submitted: December 12, 2014
Results First Posted: January 2, 2015
Last Update Posted: August 20, 2015